Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma

St. Petersburg State Pavlov Medical University30 enrolled

Overview

A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

Nivolumab 40 mg in 4 ml InjectionDRUG

40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis: Histologically confirmed Hodgkins lymphoma * Relapsed or refractory disease after at least two prior lines of treatment * Age 18-70 years old * Signed informed consent * No severe concurrent illness Exclusion Criteria: * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Karnofsky index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent * Active or prior documented autoimmune disease requiring systemic treatment.

Locations (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria

Time frame: 12 months

Secondary Outcomes

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Time frame: 12 months

Duration of Response (DOR)

Time frame: 12 months

Progression-Free Survival (PFS)

Time frame: 12 months

Overall Survival (OS)

Time frame: 12 months

Data from ClinicalTrials.gov

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